Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list FX Shoulder USA with 11 510(k) clearances. The most recent is a 510(k) clearance dated May 15, 2024: Full Wedge Lateralized and Augmented Baseplates.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 15, 2024 | Full Wedge Lateralized and Augmented BaseplatesK240278 · PHX | 510(k) clearances |
| Jun 5, 2023 | FX V135(TM) Shoulder ProsthesisK223801 · PHX | 510(k) clearances |
| Nov 7, 2022 | Humeris® 135 Shoulder SystemK222936 · PHX | 510(k) clearances |
| Jun 7, 2022 | FX V135 Shoulder ProsthesisK213117 · PHX | 510(k) clearances |
| Aug 25, 2021 | Lateralized and Augmented BaseplatesK210790 · PHX | 510(k) clearances |
| Feb 16, 2021 | Easytech® Anatomical Shoulder SystemK201391 · PKC | 510(k) clearances |
| Jul 16, 2020 | TiN Coated Humeral HeadK191698 · KWT | 510(k) clearances |
| Jul 15, 2020 | Humelock TiN Coated GlenosphereK191146 · PHX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
